TY - JOUR
T1 - Identifying effective and feasible interventions to accelerate functional recovery from hospitalization in older adults
T2 - A randomized controlled pilot trial
AU - Deer, Rachel R.
AU - Dickinson, Jared
AU - Fisher, Steve R.
AU - Ju, Hyunsu
AU - Volpi, Elena
N1 - Funding Information:
This study was conducted with the support of the National Dairy Council ( 1229 ), the UTMB Claude D. Pepper OAIC ( P30 AG024832 ) from the National Institute on Aging , and the UTMB Clinical and Translational Science Award ( UL1 TR001439 ) from the National Center for Advancing Translational Sciences, National Institutes of Health . The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or the National Dairy Council. Nutritional whey protein supplements will be provided by BiPro, Eden Prairie, MN, USA.
Publisher Copyright:
© 2016 Published by Elsevier Inc.
PY - 2016/7/1
Y1 - 2016/7/1
N2 - Hospitalization induces functional decline in older adults. Many geriatric patients fail to fully recover physical function after hospitalization, which increases the risk of frailty, disability, dependence, re-hospitalization, and mortality. There is a lack of evidence-based therapies that can be implemented following hospitalization to accelerate functional improvements. The aims of this Phase I clinical trial are to determine 1) the effect size and variability of targeted interventions in accelerating functional recovery from hospitalization and 2) the feasibility of implementing such interventions in community-dwelling older adults. Older patients (≥. 65 years, n = 100) will be recruited from a single site during hospitalization for an acute medical condition. Subjects will be randomized to one of five interventions initiated immediately upon discharge: 1. protein supplementation, 2. in-home rehabilitation plus placebo supplementation, 3. in-home rehabilitation plus protein supplementation, 4. single testosterone injection, or 5. isocaloric placebo supplementation. Testing will occur during hospitalization (baseline) and at 1 and 4 weeks post-discharge. Each testing session will include measures of muscle strength, physical function/performance, body composition, and psychological function. Physical activity levels will be continuously monitored throughout study participation. Feasibility will be determined through collection of the number of eligible, contacted, and enrolled patients; intervention adherence and compliance; and reasons for declining enrollment and study withdrawal. This research will determine the feasibility of post-hospitalization strategies to improve physical function in older adults. These results will also provide a foundation for performing larger, multi-site clinical trials to improve physical function and reduce readmissions in geriatric patents.
AB - Hospitalization induces functional decline in older adults. Many geriatric patients fail to fully recover physical function after hospitalization, which increases the risk of frailty, disability, dependence, re-hospitalization, and mortality. There is a lack of evidence-based therapies that can be implemented following hospitalization to accelerate functional improvements. The aims of this Phase I clinical trial are to determine 1) the effect size and variability of targeted interventions in accelerating functional recovery from hospitalization and 2) the feasibility of implementing such interventions in community-dwelling older adults. Older patients (≥. 65 years, n = 100) will be recruited from a single site during hospitalization for an acute medical condition. Subjects will be randomized to one of five interventions initiated immediately upon discharge: 1. protein supplementation, 2. in-home rehabilitation plus placebo supplementation, 3. in-home rehabilitation plus protein supplementation, 4. single testosterone injection, or 5. isocaloric placebo supplementation. Testing will occur during hospitalization (baseline) and at 1 and 4 weeks post-discharge. Each testing session will include measures of muscle strength, physical function/performance, body composition, and psychological function. Physical activity levels will be continuously monitored throughout study participation. Feasibility will be determined through collection of the number of eligible, contacted, and enrolled patients; intervention adherence and compliance; and reasons for declining enrollment and study withdrawal. This research will determine the feasibility of post-hospitalization strategies to improve physical function in older adults. These results will also provide a foundation for performing larger, multi-site clinical trials to improve physical function and reduce readmissions in geriatric patents.
KW - Exercise
KW - Geriatrics
KW - Hospitalization
KW - Physical function
KW - Protein
KW - Testosterone
UR - http://www.scopus.com/inward/record.url?scp=84971468433&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84971468433&partnerID=8YFLogxK
U2 - 10.1016/j.cct.2016.05.001
DO - 10.1016/j.cct.2016.05.001
M3 - Article
C2 - 27178766
AN - SCOPUS:84971468433
SN - 1551-7144
VL - 49
SP - 6
EP - 14
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
ER -